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  5. Other Testing Contract
  6. Extracts and Leachables Testing (E&L)

Extracts and Leachables Testing (E&L)

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last updated:Aug 19, 2022

オムピジャパン
オムピジャパン
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Acting as one of the Japan windows! Packaging materials other than Ompi products can also be contracted through our company!

Nelson Labs (formerly Toxikon Europe) is a global CRO with approximately 20 years of experience in the E&L testing business. It has received high praise for its extensive experience and knowledge, as well as its high identification rates and toxicity assessments supported by one of the industry's largest compound databases. The company supports hundreds of application data submissions to the FDA and EMA each year and provides information through various regulatory requirements and analytical technology training and seminars to pharmaceutical companies and container manufacturers worldwide. As interest in E&L testing grows in Japan, Ompi Japan is active as one of the company's points of contact in Japan. We can also accept contracts for packaging materials other than Ompi products through our services. **Features** - Providing Extractable & Leachable services for approximately 20 years (continuing from the Toxikon Europe era) - State-of-the-art analytical facilities suitable for Extractable & Leachable testing - Extensive experience and knowledge in container closure systems suitable for biopharmaceuticals and low molecular weight formulations *For more details, please refer to the related links or feel free to contact us.*

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Extracts and Leachables Testing (E&L)

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  • Related Link - https://www.stevanatogroup.com/jp/offering/analyti…

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【Other Features】 ■ Industry's largest class E&L compound database (over 6,000 compounds) ■ Troubleshooting support (resolving chemical incompatibility between pharmaceuticals and packaging materials) ■ Nelson Labs supports clients in collaboration with the SGLab analysis team, which has expertise in primary packaging materials ■ Provides rapid E&L screening data, contributing to reduced time to market for clients' products ■ Offers close explanatory support through strategic meetings on E&L testing ■ Provides "FIT-Screening Reports" (rapid initial toxicity screening tests) ■ Various training and consulting support related to E&L (workshops - conferences - seminars ...) *For more details, please refer to the related links or feel free to contact us.

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オムピジャパン

オムピジャパン

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Our company provides contract analysis services specializing not only in glass pharmaceutical containers from the Stevanato Group's pharmaceutical systems division but also in the domestic manufacturing and sales of plastic medical devices, as well as chemical analysis, material property evaluation, and physical/mechanical evaluation. Additionally, we handle engineering systems for production equipment (glass molding machines) and appearance inspection machines for primary packaging (such as syringe and vial filling machines).

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